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: "Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery

Primary Purpose

Relapse

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
immediate orthodontic retainer delivery
delayed orthodontic retainer delivery
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Relapse focused on measuring orthodontic retention

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult orthodontic patients treated with 022*028 MBT appliance with following sequence of wires- 014, 016, 16*22, 17*25, 19*25 NiTi followed by 19*25 SS. Treatment duration of 24-36 months with Optimal functional occlusion at end of treatment (PAR score >70%). Class I bimax and Class II div I with pre-treatment Little's irregularity index <6mm in both upper and lower arch. Nonsurgical and non-orthopedic patients. Non syndromic patients and no impaction of teeth except third molars. No previous orthodontic treatment. Optimal periodontal condition and Good oral hygiene. Good compliance regarding retainer wear (Cases who never missed more than 2 consecutive appointment and who reported with less no of breakages). Exclusion Criteria: Subjects with incomplete orthodontic treatment. TMJ disorder patients. Any systemic disease affecting bone and general growth. Patients with incomplete records. Patient who fail to follow up or undergo complete treatment. Patient with learning difficulties

Sites / Locations

  • Post Graduate Institute of Dental SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

control group-immediate retainer delivery

experimental group-delayed retainer delivery

Arm Description

Retainer will be given to the patients immediately [Just after debonding].

Retainer will be delivered to the patients 3 days post debonding.

Outcomes

Primary Outcome Measures

overjet
sagittal distance between upper and lower incisors
overjet
sagittal distance between upper and lower incisors
overjet
sagittal distance between upper and lower incisors
overjet
sagittal distance between upper and lower incisors
overjet
sagittal distance between upper and lower incisors
contact point displacement
displacement of contact points in anterior teeth
contact point displacement
displacement of contact points in anterior teeth
contact point displacement
displacement of contact points in anterior teeth
contact point displacement
displacement of contact points in anterior teeth
contact point displacement
displacement of contact points in anterior teeth
Overbite
vertical overlap of upper and lower incisors
Overbite
vertical overlap of upper and lower incisors
Overbite
vertical overlap of upper and lower incisors
Overbite
vertical overlap of upper and lower incisors
Overbite
vertical overlap of upper and lower incisors
Intermolar width
transverse distance between the first molars
Intermolar width
transverse distance between the first molars
Intermolar width
transverse distance between the first molars
Intermolar width
transverse distance between the first molars
Intermolar width
transverse distance between the first molars
Intercanine width
transverse distance between canine
Intercanine width
transverse distance between canine
Intercanine width
transverse distance between canine
Intercanine width
transverse distance between canine
Intercanine width
transverse distance between canine

Secondary Outcome Measures

Full Information

First Posted
July 27, 2022
Last Updated
May 26, 2023
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05879588
Brief Title
: "Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery
Official Title
Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery-A Randomized Control Trial"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
April 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Maintaining teeth in their corrected position after orthodontic treatment is one of the most challenging part of orthodontic treatment and hence a period of stabilization termed as retention is provided after orthodontic treatment. Retention is one of the most important phase of orthodontic treatment that attempts to keep teeth in the corrected positions after treatment with orthodontic braces. Following literature search there is no scientific evidence for the timing of retainer delivery.The present study is designed to know if post orthodontic tooth movement vary with different time of retainer delivery and since there is unusual delay after debonding as the retainer is fabricated at the laboratory. Such a study will help us to find out within which time period the retainer should be delivered
Detailed Description
The proposed study will be a prospective, non-pharmacological, single blind, randomized clinical trial to evaluate if there is a difference in transverse (X axis), A-P(Y-axis) and Vertical plane(Z-axis) of dentition in two group of post orthodontic treatment patients with immediate retainer delivery in one group and post 3 days retainer delivery in other group of patients. The present study will be conducted in the Department of Orthodontic and Dentofacial Orthopedics, P.G.I.D.S, Pt. B.D Sharma University of health sciences, Rohtak. The study will be carried out after the institutional approval obtained from ethical committee. A sample size of 18 patients was calculated keeping confidence interval 95% with power 80%. Accounting for a 10% drop out rate, 20 patients will be enrolled in each group. Patient will be randomly allocated to the study group by a person not involved in the trial using computer generated randomization list. Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient.Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z-axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient. T0 - Baseline records, at the time of debonding. T1 - Records obtained at the time of retainer delivery. T2 - Records obtained after 1 month of retainer delivery. T3 - Records obtained after 3 months of retainer delivery. T4 - Records obtained after 6 months of retainer delivery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse
Keywords
orthodontic retention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group-immediate retainer delivery
Arm Type
Other
Arm Description
Retainer will be given to the patients immediately [Just after debonding].
Arm Title
experimental group-delayed retainer delivery
Arm Type
Active Comparator
Arm Description
Retainer will be delivered to the patients 3 days post debonding.
Intervention Type
Other
Intervention Name(s)
immediate orthodontic retainer delivery
Intervention Description
post orthodontic treatment patients will be given orthodontic retainer immediately after debonding
Intervention Type
Other
Intervention Name(s)
delayed orthodontic retainer delivery
Intervention Description
post orthodontic treatment patients will be given orthodontic retainer after 3 days of debonding
Primary Outcome Measure Information:
Title
overjet
Description
sagittal distance between upper and lower incisors
Time Frame
T0-baseline on the day of debonding
Title
overjet
Description
sagittal distance between upper and lower incisors
Time Frame
T1- 3 days after debonding
Title
overjet
Description
sagittal distance between upper and lower incisors
Time Frame
T2- 1 month after debonding
Title
overjet
Description
sagittal distance between upper and lower incisors
Time Frame
T3- 3 months after debonding
Title
overjet
Description
sagittal distance between upper and lower incisors
Time Frame
T4- 6 months after debonding
Title
contact point displacement
Description
displacement of contact points in anterior teeth
Time Frame
T0-baseline on the day of debonding
Title
contact point displacement
Description
displacement of contact points in anterior teeth
Time Frame
T1- 3 days after debonding
Title
contact point displacement
Description
displacement of contact points in anterior teeth
Time Frame
T2- 1 month after debonding
Title
contact point displacement
Description
displacement of contact points in anterior teeth
Time Frame
T3- 3 months after debonding
Title
contact point displacement
Description
displacement of contact points in anterior teeth
Time Frame
T4- 6 months after debonding
Title
Overbite
Description
vertical overlap of upper and lower incisors
Time Frame
T0- Baseline on the day of debonding
Title
Overbite
Description
vertical overlap of upper and lower incisors
Time Frame
T1- 3 days after debonding
Title
Overbite
Description
vertical overlap of upper and lower incisors
Time Frame
T2- 1 month after debonding
Title
Overbite
Description
vertical overlap of upper and lower incisors
Time Frame
T3- 3 months after debonding
Title
Overbite
Description
vertical overlap of upper and lower incisors
Time Frame
T4- 6 months after debonding
Title
Intermolar width
Description
transverse distance between the first molars
Time Frame
T0-baseline on the day of debonding
Title
Intermolar width
Description
transverse distance between the first molars
Time Frame
T1- 3 days after debonding
Title
Intermolar width
Description
transverse distance between the first molars
Time Frame
T2- 1 month after debonding
Title
Intermolar width
Description
transverse distance between the first molars
Time Frame
T3- 3 months after debonding
Title
Intermolar width
Description
transverse distance between the first molars
Time Frame
T4- 6 months after debonding
Title
Intercanine width
Description
transverse distance between canine
Time Frame
T0-baseline on the day of debonding
Title
Intercanine width
Description
transverse distance between canine
Time Frame
T1- 3 days after debonding
Title
Intercanine width
Description
transverse distance between canine
Time Frame
T2- 1 month after debonding
Title
Intercanine width
Description
transverse distance between canine
Time Frame
T3- 3 months after debonding
Title
Intercanine width
Description
transverse distance between canine
Time Frame
T4- 6 months after debonding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult orthodontic patients treated with 022*028 MBT appliance with following sequence of wires- 014, 016, 16*22, 17*25, 19*25 NiTi followed by 19*25 SS. Treatment duration of 24-36 months with Optimal functional occlusion at end of treatment (PAR score >70%). Class I bimax and Class II div I with pre-treatment Little's irregularity index <6mm in both upper and lower arch. Nonsurgical and non-orthopedic patients. Non syndromic patients and no impaction of teeth except third molars. No previous orthodontic treatment. Optimal periodontal condition and Good oral hygiene. Good compliance regarding retainer wear (Cases who never missed more than 2 consecutive appointment and who reported with less no of breakages). Exclusion Criteria: Subjects with incomplete orthodontic treatment. TMJ disorder patients. Any systemic disease affecting bone and general growth. Patients with incomplete records. Patient who fail to follow up or undergo complete treatment. Patient with learning difficulties
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rekha sharma, MDS
Phone
7982391690
Ext
+91
Email
rajsringari@gmail.com
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rekha Sharma, MDS
Phone
7982391690
Ext
+91
Email
rajsringari@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr Vibhore Sharma, BDS
First Name & Middle Initial & Last Name & Degree
Dr Rekha Sharma, MDS
First Name & Middle Initial & Last Name & Degree
Dr Shikha Tewari, MDS
First Name & Middle Initial & Last Name & Degree
Dr Manisha kamal Kukreja, MDS
First Name & Middle Initial & Last Name & Degree
Dr Davender Kumar, MDS

12. IPD Sharing Statement

Plan to Share IPD
No

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